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NCT05831124 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About a Type of Pneumococcal Vaccine With a New Ingredient (PF-07872411) Intended to Enhance the Effects of the Vaccine Which is Given to Adults
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT05831124 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 90 participants.
The verdict
NCT05831124, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infections and sinusitis. Meningitis is an infection in which the tissue around the brain and spine is swollen. Sepsis is a very serious infection in your blood caused by a germ (a bacteria). Sinusitis is when your sinuses (the air-filled spaces inside your nose and head), are infected. This study is seeking for healthy participants who: * are above 50 years of age and less than 64 years of age. * have not taken any vaccine for pneumococcal diseases before. * have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine. All participants will receive a single study vaccine shot in the upper arm muscle at the study clinic. The study will compare the experiences of people receiving the vaccine with a new ingredient in the vaccine to those without the new ingredient. This will be done by comparing 2 different dose levels of the new ingredient. It will also be compared against people who receive the vaccine without the new ingredient and at different dose levels. This will help the study team establish if the vaccine with a new ingredient is safe and effective. Participants will take part in this study for about 12 months. During this time participants will have up to 6 clinic visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these visits. Some participants will need to have blood taken for laboratory tests before they can be judged to be eligible to be included in the study.
Interventions
- OTHER Low dose multivalent pneumococcal conjugate vaccine formulation A
- OTHER Low dose multivalent pneumococcal conjugate vaccine formulation B
- BIOLOGICAL Low dose of multivalent pneumococcal conjugate vaccine control
- BIOLOGICAL Standard dose multivalent pneumococcal conjugate vaccine control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2024-06-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05831124
The ClinicalTrials.gov registry entry for NCT05831124 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Low dose multivalent pneumococcal conjugate vaccine formulation A is the first listed.
NCT05831124 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05831124 about?
NCT05831124 is a clinical study titled "A Study to Learn About a Type of Pneumococcal Vaccine With a New Ingredient (PF-07872411) Intended to Enhance the Effects of the Vaccine Which is Given to Adults". The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infe...
What is the current status of trial NCT05831124?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2023-04-19. Estimated completion is 2024-06-26.
What interventions are being tested in trial NCT05831124?
The interventions under investigation include: Low dose multivalent pneumococcal conjugate vaccine formulation A (OTHER), Low dose multivalent pneumococcal conjugate vaccine formulation B (OTHER), Low dose of multivalent pneumococcal conjugate vaccine control (BIOLOGICAL), Standard dose multivalent pneumococcal conjugate vaccine control (BIOLOGICAL).
Who is sponsoring clinical trial NCT05831124?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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